SL-100 ND:YAG LASER FOR UROLOGIC SURGERY— 510(k) K871516

Name: FDA 510(k) clearance K871516
Creator: U.S. Food and Drug Administration
Published: 1987-07-09

Substantially Equivalent

Medical Energy, Inc.

FDA 510(k) clearance K871516 for SL-100 ND:YAG LASER FOR UROLOGIC SURGERY, Substantially Equivalent on 1987-07-09. Applicant: Medical Energy, Inc.. Device class: 2.

Clearance details

Applicant: Medical Energy, Inc.
Product code: Code LNK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1987-04-20
Decision date: 1987-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pensacola, FL, US

Download summary PDF View on FDA.gov ↗

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K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE1988-04-14

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